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OpenTrials
Completed

NCT Number: NCT00913952

To Demonstrate the Relative Bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed and Fasted Conditions

To demonstrate the relative bioavailability of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride capsules under fed and fasted conditions.

Completed

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion criteria

  • Positive test results for HIV or hepatitis B or C.
  • Treatment for drug or alcohol dependence.

Treatment and study plan

Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fasting Conditions

Drug

Geneva 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

Drug

Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules Under Fed Conditions

Drug

Primary outcomes

  1. Bioequivalence based on AUC and Cmax

    Time frame: 53 days

Sponsors and collaborators

Lead sponsor

Sandoz

Industry

Registry information

Official study title

Comparative, Randomized, 3-way Crossover Bioavailability Study of Geneva and Basel (Anafranil) 25 mg Clomipramine Hydrochloride Capsules In Health Adult Males Under Fed and Fasted Conditions

Important dates

Study start
1994
Primary completion
1994
Study completion
1994
First posted
Jun 4, 2009
Registry last updated
Mar 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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